20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OVUSENSE
FDA 510(k)
FDA Unclassified
·Unknown
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D
FDA 510(k)
FDA Class 2
·Radiology
SPRINT QUATTRO SECURE S
FDA Adverse Event
Death
·MPRI·Product code LWS·May 21, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 13, 2011
ACCU-CHEK ULTRAFLEX INFUSION SET
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·August 15, 2008
epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·September 6, 2023
LARGE HEXAGONAL SCREWDRIVER WITH T-HANDLE
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HXX·January 27, 2020
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·December 28, 2011
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·December 28, 2011
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·December 28, 2011
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·December 28, 2011
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·December 28, 2011
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·December 28, 2011
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·December 28, 2011
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·December 28, 2011
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·December 28, 2011
DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
FDA Adverse Event
Injury
·COOK INC·Product code DQO·August 10, 2023
CERTAS INLIN VLV ONLY W/SPHNGD
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·July 12, 2017
TRANSMITTER MMT-7841ZW GST5G OUS
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PQF·February 6, 2026